FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc. (St Jude Medical): v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Recall number
- Z-1854-2021
- Recalling firm
- Abbott Laboratories Inc. (St Jude Medical)
- Product
- v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals during cardiac EP studies.
- Status
- Terminated
- Initiated
- 2021-05-05
- Posted
- not on file
- Terminated
- 2024-06-18
- Reason
- Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of MI, KS, MO, TX.
- Lot, serial or model codes
- Serial Numbers: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, 18917926
- 510(k) numbers
- ["K210392"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 1000139754
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28